{"title":"日本汉方药立昆士、释骨坎佐和哥瑞散对日本甲状腺癌患者Lenvatinib血药浓度的影响。","authors":"Kazuma Fujita, Akifumi Suzuki, Mitsuji Nagahama, Kiminori Sugino, Chie Masaki, Koichi Ito, Masatomo Miura","doi":"10.1007/s40801-024-00467-6","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Kampo medicines are often used in Japan as therapy for the side effects induced by oral kinase inhibitors. However, the pharmacokinetic interactions between Kampo medicines and oral kinase inhibitors such as lenvatinib have not been studied.</p><p><strong>Objective: </strong>We investigated the effects of Kampo medicines (rikkunshito, shakuyakukanzoto and goreisan) on the steady-state plasma trough concentration (C<sub>0</sub>) of lenvatinib in patients with thyroid cancer.</p><p><strong>Methods: </strong>Thirty-nine patients receiving lenvatinib therapy at Ito Hospital between May 2015 and December 2019 were enrolled. The mean C<sub>0</sub> of lenvatinib with Kampo medicine, at the same dose as before initiating Kampo medicines, was used.</p><p><strong>Results: </strong>After the repeated administration of rikkunshito (n = 21), shakuyakukanzoto (n = 10) or goreisan (n = 8), the mean C<sub>0</sub> of lenvatinib and the laboratory test values of patients did not change significantly. In contrast to rikkunshito, which alleviates emesis by enhancing gastric emptying, the C<sub>0</sub> values of lenvatinib with a proton pump inhibitor (PPI) (n = 16) or histamine H<sub>2</sub> receptor antagonist (H2RA) (n = 4) were significantly lower than the C<sub>0</sub> values without a PPI or H2RA (P = 0.007). The mean (range) change rate of the C<sub>0</sub> of lenvatinib with a PPI or H2RA versus without a PPI or H2RA was 88.6% (69.9-115%), and was significantly greater than the change rate for rikkunshito (P = 0.029). There was no significant difference between the C<sub>0</sub> of lenvatinib with a prokinetic agent (n = 7) versus without a prokinetic agent (P = 0.365).</p><p><strong>Conclusions: </strong>Although these Kampo medicines are reported to inhibit drug-metabolizing enzymes and drug transporters, the risk of drug interactions for patients receiving lenvatinib therapy is low. Patients should feel confident that they can receive Kampo medicines as supportive care for lenvatinib therapy without a risk of drug interactions that could affect treatment efficacy.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":""},"PeriodicalIF":1.9000,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Effects of the Japanese Kampo Medicines Rikkunshito, Shakuyakukanzoto and Goreisan on Lenvatinib Plasma Concentrations in Japanese Patients with Thyroid Cancer.\",\"authors\":\"Kazuma Fujita, Akifumi Suzuki, Mitsuji Nagahama, Kiminori Sugino, Chie Masaki, Koichi Ito, Masatomo Miura\",\"doi\":\"10.1007/s40801-024-00467-6\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Kampo medicines are often used in Japan as therapy for the side effects induced by oral kinase inhibitors. However, the pharmacokinetic interactions between Kampo medicines and oral kinase inhibitors such as lenvatinib have not been studied.</p><p><strong>Objective: </strong>We investigated the effects of Kampo medicines (rikkunshito, shakuyakukanzoto and goreisan) on the steady-state plasma trough concentration (C<sub>0</sub>) of lenvatinib in patients with thyroid cancer.</p><p><strong>Methods: </strong>Thirty-nine patients receiving lenvatinib therapy at Ito Hospital between May 2015 and December 2019 were enrolled. The mean C<sub>0</sub> of lenvatinib with Kampo medicine, at the same dose as before initiating Kampo medicines, was used.</p><p><strong>Results: </strong>After the repeated administration of rikkunshito (n = 21), shakuyakukanzoto (n = 10) or goreisan (n = 8), the mean C<sub>0</sub> of lenvatinib and the laboratory test values of patients did not change significantly. In contrast to rikkunshito, which alleviates emesis by enhancing gastric emptying, the C<sub>0</sub> values of lenvatinib with a proton pump inhibitor (PPI) (n = 16) or histamine H<sub>2</sub> receptor antagonist (H2RA) (n = 4) were significantly lower than the C<sub>0</sub> values without a PPI or H2RA (P = 0.007). The mean (range) change rate of the C<sub>0</sub> of lenvatinib with a PPI or H2RA versus without a PPI or H2RA was 88.6% (69.9-115%), and was significantly greater than the change rate for rikkunshito (P = 0.029). There was no significant difference between the C<sub>0</sub> of lenvatinib with a prokinetic agent (n = 7) versus without a prokinetic agent (P = 0.365).</p><p><strong>Conclusions: </strong>Although these Kampo medicines are reported to inhibit drug-metabolizing enzymes and drug transporters, the risk of drug interactions for patients receiving lenvatinib therapy is low. Patients should feel confident that they can receive Kampo medicines as supportive care for lenvatinib therapy without a risk of drug interactions that could affect treatment efficacy.</p>\",\"PeriodicalId\":11282,\"journal\":{\"name\":\"Drugs - Real World Outcomes\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":1.9000,\"publicationDate\":\"2024-12-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Drugs - Real World Outcomes\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1007/s40801-024-00467-6\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"PHARMACOLOGY & PHARMACY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Drugs - Real World Outcomes","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1007/s40801-024-00467-6","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
Effects of the Japanese Kampo Medicines Rikkunshito, Shakuyakukanzoto and Goreisan on Lenvatinib Plasma Concentrations in Japanese Patients with Thyroid Cancer.
Background: Kampo medicines are often used in Japan as therapy for the side effects induced by oral kinase inhibitors. However, the pharmacokinetic interactions between Kampo medicines and oral kinase inhibitors such as lenvatinib have not been studied.
Objective: We investigated the effects of Kampo medicines (rikkunshito, shakuyakukanzoto and goreisan) on the steady-state plasma trough concentration (C0) of lenvatinib in patients with thyroid cancer.
Methods: Thirty-nine patients receiving lenvatinib therapy at Ito Hospital between May 2015 and December 2019 were enrolled. The mean C0 of lenvatinib with Kampo medicine, at the same dose as before initiating Kampo medicines, was used.
Results: After the repeated administration of rikkunshito (n = 21), shakuyakukanzoto (n = 10) or goreisan (n = 8), the mean C0 of lenvatinib and the laboratory test values of patients did not change significantly. In contrast to rikkunshito, which alleviates emesis by enhancing gastric emptying, the C0 values of lenvatinib with a proton pump inhibitor (PPI) (n = 16) or histamine H2 receptor antagonist (H2RA) (n = 4) were significantly lower than the C0 values without a PPI or H2RA (P = 0.007). The mean (range) change rate of the C0 of lenvatinib with a PPI or H2RA versus without a PPI or H2RA was 88.6% (69.9-115%), and was significantly greater than the change rate for rikkunshito (P = 0.029). There was no significant difference between the C0 of lenvatinib with a prokinetic agent (n = 7) versus without a prokinetic agent (P = 0.365).
Conclusions: Although these Kampo medicines are reported to inhibit drug-metabolizing enzymes and drug transporters, the risk of drug interactions for patients receiving lenvatinib therapy is low. Patients should feel confident that they can receive Kampo medicines as supportive care for lenvatinib therapy without a risk of drug interactions that could affect treatment efficacy.
期刊介绍：
Drugs - Real World Outcomes targets original research and definitive reviews regarding the use of real-world data to evaluate health outcomes and inform healthcare decision-making on drugs, devices and other interventions in clinical practice. The journal includes, but is not limited to, the following research areas: Using registries/databases/health records and other non-selected observational datasets to investigate: drug use and treatment outcomes prescription patterns drug safety signals adherence to treatment guidelines benefit : risk profiles comparative effectiveness economic analyses including cost-of-illness Data-driven research methodologies, including the capture, curation, search, sharing, analysis and interpretation of ‘big data’ Techniques and approaches to optimise real-world modelling.
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